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Worsening Heart FailurePhase 2CRAFT-WHFNCT06815471

CRF2 Agonist for the Treatment of Worsening Heart Failure

A Phase 2 study testing COR-1167 in people with Worsening Heart Failure, run by Corteria Pharmaceuticals at 55 sites in 8 countries.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

This study assesses the effects of the investigational drug COR-1167 in subjects hospitalised due to worsening of heart failure (HF) Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Worsening Heart Failure
What is being tested?
COR-1167
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
55 sitesin 8 countries
Study dates
7 Aug 2025to Dec 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed written informed consent
  • Heart failure hospitalization (HFH) during previous 12 months
  • Prescribed an oral loop diuretic for at least 1 month preceding the index event
  • NT-proBNP ≥1,000 pg/mL or BNP ≥250 pg/mL
  • Requires treatment with i.v. diuretics for volume overload
  • At least 1 risk factor for diuretic resistance
  • Admitted to the hospital not more than 48 hours prior to randomization

Who cannot join

  • Index event primarily triggered by an acute event (e.g. AMI, PE, arrhythmia)
  • Requirement for i.v. inotropic therapy or i.v. vasodilators, mechanical ventilation, high-flow oxygen therapy, or NIV
  • Requirement for, or planned use of LVADs, IABP, or any type of MCS
  • History of solid organ transplant or active on a transplant list
  • SBP <100 mmHg
  • eGFR < 20 mL/min/1.73 m2
Show all 15Show fewer
  • CABG, PCI, implantation of CRT, heart valve procedure or any cardiac surgery within 1 month prior to screening or planned during the study
  • Severe stenotic cardiac valvular disease
  • Severe chronic pulmonary disease requiring chronic steroid therapy or chronic oxygen therapy (> 2 L/min)
  • Uncorrected severe hyperthyroidism or hypothyroidism
  • Severe restrictive, obstructive, or infiltrative cardiomyopathy
  • Body weight < 70 kg
  • Use of any investigational drug(s) within 5 half-lives of screening
  • At high risk of death (defined as life expectancy ≤1 year) from causes other than heart failure or any disease that, in the opinion of the Investigator, will preclude their safe participation in this study, and will make implementation of the protocol or interpretation of the study results difficult
  • Presence of any other conditions (e.g. geographic, social) actual or anticipated, that the Investigator feels would restrict or limit the subject's participation or compliance with all study procedures Subject is the Investigator or any Subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study

Trial locations and contacts

55 sites in 8 countries.

55 sites in 8 countries

Georgia9 sites

  • Aleksandre Aladashvili Clinic LLC

    Tbilisi, 0102

  • LTD "Israeli-Georgian Medical Research Clinic Healthycore"

    Tbilisi, 0112

  • Acad. G. Chapidze Emergency Cardiology Center LTD, Department of Internal Medicine and Medical Research

    Tbilisi, 0159

  • Acad. G.Chapidze Emergency Cardiology Center, LTD, Department of Multi-center Clinical Trials

    Tbilisi, 0159

  • Bokhua Memorial Cardiovascular Center LTD

    Tbilisi, 0159

  • St. Michael's Hospital LLC

    Tbilisi, 0159

  • Tbilisi Heart and Vascular Clinic, LTD

    Tbilisi, 0159

  • Georgian Dutch Hospital

    Tbilisi, 0167

  • LTD Tbilisi Heart Center

    Tbilisi, 0186

Other trials in Georgia

Serbia9 sites

  • Clinical Hospital Center "Dr Dragisa Misovic Dedinje"

    Belgrade, 11000

  • Institute for Cardiovascular Diseases Dedinje

    Belgrade, 11000

  • University Clinical Center of Serbia, Clinic for Cardiology, Department for the testing and treatment of congenital and acquired heart defects

    Belgrade, 11000

  • University Clinical Center of Serbia, Clinic for Cardiology, Emergency Cardiology Department

    Belgrade, 11000

  • University Clinical Center of Serbia, Clinic for Cardiology, Heart Failure Ward

    Belgrade, 11000

  • University Clinical Center Kragujevac, Clinic for Cardiology

    Kragujevac, 34000

  • General Hospital Leskovac, Cardiology Department

    Leskovac, 16000

  • University Clinical Center Nis, Clinic for Cardiology

    Niš, 18000

  • Institute For Treatment and Rehabilitation "Niska Banja"

    Niška Banja, 18205

Other trials in Serbia

Poland8 sites

  • Klinika Kardiologii i Chorób Wewnętrznych z Oddziałem Intensywnego Nadzoru Kardiologicznego (OINK), Uniwersytecki Szpital Kliniczny w Białymstoku

    Bialystok, 15-276

  • I Klinika Kardiologii, Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

  • Zespół Opieki Zdrowotnej w Klodzku, Oddzial Kardiologii

    Kłodzko, 57-300

  • SP ZOZ Szpital Uniwersytecki w Krakowie

    Krakow, 30-688

  • II Klinika Kardiologii, SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi

    Lodz, 92-213

  • Kliniczny Szpital Wojewódzki nr 2 im. Św. Jadwigi Królowej w Rzeszowie

    Rzeszów, 35-301

  • Oddział Kliniczny Kardiologii i Intensywnej Terapii Kardiologicznej

    Torun, 87-100

  • Instytut Chorób Serca, Zakład Badań Klinicznych Chorób Układu Krążenia, Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

    Wroclaw, 50-556

Other trials in Poland

United States7 sites

  • Ohio State University

    Columbus, Ohio, 43210

  • Wayne State University - Detroit Receiving Hospital

    Detroit, Michigan, 48201

  • Wayne State University - Sinai Grace Hospital

    Detroit, Michigan, 48235

  • Cone Health Moses Cone Hospital

    Greensboro, North Carolina, 27401

  • Indiana University Health Methodist Hospital

    Indianapolis, Indiana, 46202

  • South Oklahoma Heart Research, LLC

    Oklahoma City, Oklahoma, 73135

  • NC Heart and Vascular Research, LLC

    Raleigh, North Carolina, 27607

Other trials in United States

Spain7 sites

  • Hospital Clínico Universitario Virgen de la Arrixaca

    El Palmar, Murcia, 30120

  • Hospital Universitario Ramon y Cajal

    Fuencarral-El Pardo, Madrid, 28034

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Universitario Hospital Virgen del Rocío

    Seville, 41013

  • Hospital Clínico Universitario de Valencia

    Valencia, Valencia, 46010

  • Consorcio Hospital General Universitario de Valencia

    Valencia, 46014

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

Romania6 sites

  • Emergency County Clinical Hospital Arad, Cardiology department

    Arad, 310037

  • Institutul de Urgenta pentru Boli Cardiovasculare "Prof. Dr. C.C. Iliescu", Cardiologie 1

    Bucharest, 022328

  • Institutul de Urgenta pentru Boli Cardiovasculare "Prof. Dr. C.C. Iliescu", Cardiologie 3

    Bucharest, 022328

  • Spitalul Clinic Colentina

    Bucharest, 20125

  • Craiova County Emergency Clinical Hospital

    Craiova, 200642

  • Spitalul Clinic Municipal de Urgenta Timisoara

    Timișoara, 300079

Other trials in Romania

Hungary5 sites

  • Semmelweis Egyetem, Általános Orvostudományi Kar, Városmajori Szív- és Érgyógyászati Klinika

    Budapest, 1122

  • Budapesti Uzsoki Utcai Kórház, Kardiológia Osztály

    Budapest, 1145

  • Pécsi Tudományegyetem, Klinikai Központ, I. sz. Belgyógyászati Klinika

    Pécs, 7624

  • Szegedi Tudományegyetem, Általános Orvostudományi Kar, Családorvosi Intézet

    Szeged, 7625

  • Zala Vármegyei Szent Rafael Kórház, Kardiológiai Osztály

    Zalaegerszeg, 8900

Other trials in Hungary

Czechia4 sites

  • Fakultní nemocnice Brno

    Brno, 62500

  • Sdružené zdravotnické zařízení Krnov

    Krnov, 79401

  • Fakultní nemocnice Ostrava

    Ostrava, 70852

  • Nemocnice Slaný

    Slaný, 27401

Other trials in Czechia

About this study

Official title: Corticotrophin Releasing Factor 2 for the Treatment of Worsening Heart Failure (WHF) - The CRAFT-WHF Study

This study assesses the effects of the investigational drug COR-1167 in subjects hospitalised due to worsening of heart failure (HF)

Read the detailed description

This is a phase 2, randomized, double-blind, placebo-controlled study designed to assess the dose-dependent effects of 3 doses of the corticotropin-releasing factor type 2 (CRF2) peptide agonist, COR-1167, in subjects with WHF, defined as subjects requiring urgent administration of intravenous (i.v.) diuretics due to worsening of signs and symptoms of heart failure (HF) associated with volume overload

Being tested
COR-1167, Placebo
Keywords
COR-1167, Hospitalised heart failure, WHF

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COR-1167Drug

    28-day treatment

  • PlaceboDrug

    28-day treatment

Study groups in NCT06815471
Study groupRoleWhat they receive
COR-1167 low doseExperimentalNot described
Receives: Drug: COR-1167
COR-1167 intermediate doseExperimentalNot described
Receives: Drug: COR-1167
COR-1167 high doseExperimentalNot described
Receives: Drug: COR-1167
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Natriuresis

    Urinary sodium excretion

    Measured: 24 hours

  2. Body weight

    Changes in body weight

    Measured: 7 days

  3. NT-proBNP

    Changes in NT-proBNP

    Measured: 7 days

  4. Kansas City Cardiomyopathy Questionnaire (KCCQ)-Total Symptom Score (TSS)

    Changes in KCCQ-TSS - The score ranges from 0 to 100 with higher score indicating a better health status

    Measured: 28 days

  5. Left Atrial Volume index (LAVi)

    Changes in LAVi - LAV-i is an index of cardiac function measured by echocardiogram

    Measured: 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2025
  2. Study start7 Aug 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Why it stopped: The DSMB recommended pausing the enrollment to give time to the Executive Committee to revise the eligibility criteria to exclude patients who may be in impending cardiogenic shock or in other ways too ill to safely participate in the trial.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06815471
Sponsor's protocol ID
COR1167-201
Acronym
CRAFT-WHF
Status last verified
Jul 2026
First submitted
3 Feb 2025
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: This is not a phase 3 trial that would benefit from IPD sharing

Publications

  • Rademaker MT, Charles CJ, Ellmers LJ, Lewis LK, Nicholls MG, Richards AM. Prolonged urocortin 2 administration in experimental heart failure: sustained hemodynamic, endocrine, and renal effects. Hypertension. 2011 Jun;57(6):1136-44. doi: 10.1161/HYPERTENSIONAHA.111.173203. Epub 2011 May 2.

    PubMed 21536988

  • Rademaker MT, Charles CJ, Nicholls MG, Richards AM. Urocortin 2 inhibits furosemide-induced activation of renin and enhances renal function and diuretic responsiveness in experimental heart failure. Circ Heart Fail. 2009 Nov;2(6):532-40. doi: 10.1161/CIRCHEARTFAILURE.109.861336. Epub 2009 Sep 22.

    PubMed 19919977

  • Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; Authors/Task Force Members; Document Reviewers. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016 Aug;18(8):891-975. doi: 10.1002/ejhf.592. Epub 2016 May 20. No abstract available.

    PubMed 27207191

  • Chan WY, Frampton CM, Crozier IG, Troughton RW, Richards AM. Urocortin-2 infusion in acute decompensated heart failure: findings from the UNICORN study (urocortin-2 in the treatment of acute heart failure as an adjunct over conventional therapy). JACC Heart Fail. 2013 Oct;1(5):433-41. doi: 10.1016/j.jchf.2013.07.003. Epub 2013 Sep 11.

    PubMed 24621976

  • Rubio-Gracia J, Demissei BG, Ter Maaten JM, Cleland JG, O'Connor CM, Metra M, Ponikowski P, Teerlink JR, Cotter G, Davison BA, Givertz MM, Bloomfield DM, Dittrich H, Damman K, Perez-Calvo JI, Voors AA. Prevalence, predictors and clinical outcome of residual congestion in acute decompensated heart failure. Int J Cardiol. 2018 May 1;258:185-191. doi: 10.1016/j.ijcard.2018.01.067.

    PubMed 29544928

  • Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):399-410. doi: 10.1161/01.cir.0000442015.53336.12. No abstract available.

    PubMed 24446411

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing COR-1167 in people with Worsening Heart Failure, run by Corteria Pharmaceuticals at 55 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in Georgia, Serbia, Poland, United States, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Natriuresis (time frame: 24 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06815471, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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