Study on COR-1167 for Patients with Worsening Heart Failure

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What is this study about?

This study is testing a medication called COR-1167 for people with worsening heart failure. Heart failure is a condition where the heart cannot pump blood effectively throughout the body, leading to fluid buildup, shortness of breath, and fatigue. When heart failure worsens, patients may experience increased fluid retention and more severe symptoms that require hospitalization and treatment with intravenous medications.

The purpose of this study is to evaluate how different doses of COR-1167 compare to a placebo in treating worsening heart failure. COR-1167 is a Corticotrophin Releasing Factor 2 Agonist, which is a type of medication being investigated for its potential to help the body eliminate excess fluid and improve heart function. The medication will be given as a daily subcutaneous injection (under the skin) for 4 weeks.

During the study, researchers will monitor several factors including: how much urine participants produce (natriuresis), changes in body weight, levels of certain heart failure markers in the blood (NT-proBNP), heart failure symptoms using a questionnaire, and measurements of heart structure (specifically the Left Atrial Volume Index, which indicates how much the upper left chamber of the heart is enlarged). The study will also evaluate the safety of the medication by monitoring for side effects and checking laboratory values.

1 Hospital Admission and Start of Trial

You will begin the trial after being admitted to the hospital for worsening heart failure (a condition where your heart cannot pump blood effectively, leading to fluid buildup in your body).

To qualify for the study, you must have been admitted to the hospital no more than 48 hours before joining the trial and still have significant fluid overload (at least 5 kg or 11 pounds of excess fluid) requiring intravenous diuretics.

You must have had a heart failure hospitalization in the previous 12 months and been taking an oral water pill (loop diuretic) for at least 1 month before this hospital admission.

2 Randomization and Treatment Assignment

You will be randomly assigned to receive either COR-1167 (an investigational medication) or a placebo (a solution that looks the same but contains no active ingredient).

If assigned to COR-1167, you will receive one of three different doses of the medication.

The medication or placebo will be given as a daily injection under the skin (subcutaneous injection) using a pre-filled syringe.

3 4-Week Treatment Period

You will receive daily injections of either COR-1167 or placebo for a total of 4 weeks.

Throughout this period, medical staff will monitor your condition and collect data on several important measures:

4 Measurements and Assessments

During the 4-week treatment period, the following will be regularly measured:

Natriuresis: The amount of sodium excreted in your urine, which indicates how well your body is eliminating excess fluid.

Body weight: Regular weight measurements will track fluid loss.

NT-proBNP levels: Blood tests measuring a protein that increases when heart failure worsens.

KCCQ Total Symptom Score: You’ll complete questionnaires about your heart failure symptoms.

Left Atrial Volume Index (LAVi): Imaging tests to measure a specific heart chamber size, which can indicate heart failure severity.

5 Safety Monitoring

Throughout the study, your safety will be closely monitored through:

Blood and urine tests: To check various body functions including kidney function.

Vital signs: Regular measurement of blood pressure, heart rate, breathing rate, and body temperature.

Physical examinations: To assess your overall health status.

Electrocardiogram (ECG): A test that records the electrical activity of your heart.

Monitoring for side effects: Any unusual symptoms or adverse events will be documented.

6 End of Treatment Assessment

After completing the 4-week treatment period, a final set of assessments will be conducted.

Blood samples will be taken to check for anti-drug antibodies (proteins your body might produce in response to the study medication).

All the measurements taken during the study will be evaluated to determine how the different doses of COR-1167 affected your heart failure symptoms compared to placebo.

Who Can Join the Study?

  • You must have had a heart failure hospitalization during the previous 12 months
  • You must have been prescribed an oral loop diuretic (water pill to help remove excess fluid) for at least 1 month before the current event
  • Your NT-proBNP level must be ≥1,000 pg/mL or BNP level ≥250 pg/mL (these are blood tests that measure proteins released when your heart is under stress)
  • You need treatment with intravenous (IV) diuretics for fluid overload, which means you have:
    • Visible swelling (pitting edema), fluid in the abdomen (ascites), or fluid around the lungs (pleural effusion) AND
    • At least one of these signs: shortness of breath (dyspnea), crackling sounds in lungs (rales), fluid in lungs seen on imaging, or visible neck vein swelling (jugular venous distention)
  • You must have risk factors that make it harder for diuretics to work effectively (diuretic resistance)
  • You must be unable to have children or agree to use highly effective birth control from screening through 30 days after the last dose
  • You must provide signed written informed consent to participate in the study
  • You must have been admitted to the hospital no more than 48 hours before being randomly assigned to a treatment group
  • In your doctor’s opinion, you must still have significant fluid overload (at least 5 kg or 11 pounds) requiring additional IV diuretic treatment

Who Cannot Join the Study?

  • You cannot participate if you have severe kidney problems (a condition where your kidneys don’t work properly)
  • You cannot participate if you have a heart attack or unstable chest pain within the last 3 months
  • You cannot participate if you have heart valve disease (problems with the valves that control blood flow through your heart)
  • You cannot participate if you have had a heart transplant or are waiting for one
  • You cannot participate if you have a device to help your heart pump blood
  • You cannot participate if you are pregnant or breastfeeding
  • You cannot participate if you have a severe infection
  • You cannot participate if you have liver disease (a condition affecting your liver’s ability to function)
  • You cannot participate if you have low blood pressure that causes symptoms
  • You cannot participate if you have been in another clinical trial within the last 30 days
  • You cannot participate if you are allergic to the study medication or any of its ingredients
  • You cannot participate if you have a history of alcohol or drug abuse

Where you can join this trial?

Verified and Recommended Sites

Site Name City Country Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie Lublin Poland

Verified Sites

Other Sites

Site Name City Country Status
Central Hospital Of Northern Pest Military Hospital Budapest Hungary
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Spitalul Clinic Judetean De Urgenta Craiova Craiova Romania
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu Torun Poland
Institutul De Urgenta Pentru Boli Cardiovasculare Prof. Dr. C. C. Iliescu Bucharest Romania
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego Walbrzych Poland
Spitalul Clinic Colentina Bucuresti Bucharest Romania
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Spitalul Clinic Municipal De Urgenta Timisoara Timisoara Romania
Nemocnice Slany Slany Czechia
Gornoslaskie Centrum Mwdyczne Katowice Poland
Virgen del Rocío University Hospital Sevilla Spain
Fakultni Nemocnice Brno Brno Czechia
Semmelweis University Budapest Hungary
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Universidade De Santiago De Compostela Santiago De Compostela Spain
Hospital General Universitario De Valencia Valencia Spain
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Zala Megyei Szent Rafael Korhaz Zalaegerszeg Hungary
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
University Of Pecs Pecs Hungary
University Of Szeged Szeged Hungary
University Hospital Ostrava Ostrava Czechia
Budapesti Uzsoki Utcai Korhaz Budapest Hungary
Scfplpvq zlyxyrhbrhyc zlydzske Kwyyw piwkwhjftza olodumtxwv Krnov Czechia
Sxwrrsztioq Pyylsbnoy Zkkcww Zljygnpo Ovzlvr Zqbkjasjhk W Pjszcjswot Przasnysz Poland
Zymvlj Olzxds Zkeohkwzju W Kwovkey Klodzko Poland
Cixmyjhn Srmpzixk Ijbauxid L'hospitalet De Llobregat Spain
Perwculgi Iewrrmbp Mbhyoygk Mxsrimuwdokx Skcnb Wyosiwgtqlsx I Auqzqauliybsp Warsaw Poland
Ucqywqpnsxkytc Cctunfc Kjqyzrgbd Gdansk Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not yet recruiting
22.07.2025
Hungary Hungary
Not yet recruiting
22.07.2025
Poland Poland
Not yet recruiting
22.07.2025
Romania Romania
Not yet recruiting
22.07.2025
Spain Spain
Not yet recruiting
22.07.2025

Trial locations

COR-1167 is an experimental medication that acts as a Corticotrophin Releasing Factor 2 Agonist. It’s being studied for treating worsening heart failure. In this trial, it’s administered once daily as an injection under the skin (subcutaneously) for a period of 4 weeks. The study is examining how this medication affects fluid balance in the body, heart failure symptoms, and heart function.

Worsening Heart Failure – A clinical condition characterized by a deterioration in the heart’s ability to pump blood effectively, leading to a progression of heart failure symptoms. It represents an exacerbation of chronic heart failure where the heart muscle becomes increasingly unable to meet the body’s demands for blood and oxygen. Patients typically experience increased fluid retention, shortness of breath, fatigue, and reduced exercise capacity. The condition involves progressive ventricular remodeling and neurohormonal activation that further impair cardiac function. Worsening heart failure may occur gradually or suddenly as an acute decompensation of previously stable heart failure.

Trial ID:
2024-518951-52-00
Protocol code:
COR1167-201
NCT ID:
NCT06815471
Trial Phase:
Therapeutic exploratory (Phase II)

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