Heart Failure and Reduced Ejection FractionPhase 4PRIMA-HFNCT07243119
PRIMA-HF: Predicting Myocardial Recovery in Heart Failure Using Cardiac Imaging HAI-HF: High Dosing vs. Standard Dosing Adenosine During Myocardial Perfusion in Heart Failure
A Phase 4 study testing HAI-HF: Adenosine Stress [¹⁵O]H₂O PET Imaging and Two different doses of adenosine in people with Heart Failure and Reduced Ejection Fraction and Heart Failure, run by Gødstrup Hospital at 1 site in Denmark.
Trial summary
Background: Heart failure with reduced ejection fraction (HFrEF) is a heterogeneous condition with variable potential for left ventricular ejection fraction (LVEF) recovery. While LVEF improvement and reverse remodeling predict better outcomes, the determinants that predict left ventricular recovery remain poorly… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Heart Failure and Reduced Ejection Fraction, Heart Failure
- What is being tested?
- HAI-HF: Adenosine Stress [¹⁵O]H₂O PET Imaging and Two different doses of adenosine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Dec 2025to 30 Apr 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Capable and has provided written informed consent
- LVEF ≤ 40% by echocardiography in connection with hospitalization for heart failure or in connection with outpatient evaluation for heart failure
Who cannot join
- Previous diagnosis of heart failure
- Unable to understand the patient information
- Pregnancy, as the study involves ionizing radiation.
- Current severe valvular disease (as defined by the Danish national treatment guidelines on cardio.dk)
- Atrial fibrillation with a heart rate > 130 beats per minute during the inclusion echocardiography
- Cardiac surgery within 6 months prior to inclusion
Show all 14Show fewer
- Acute exacerbation of existing chronic obstructive pulmonary disease
- Severe asthma or chronic obstructive pulmonary disease with FEV1 < 1L
- any contraindication for adenosine stress testing
- Severe renal failure < 15 mL/min/1.73m² or dialysis
- Advanced liver disease (Child-Pugh class C)
- Endocarditis at inclusion/baseline
- Isolated right-sided heart failure
- Malignant disease treated with chemotherapy or radiotherapy, or expected life expectancy under 1 year
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: PRIMA-HF PRedicting Recovery of Left Ventricular Function With Multimodality Cardiac IMAging in Patients With de Novo Heart Failure HAI-HF: High-Dose Adenosine During Perfusion Imaging in Heart Failure: Rationale and Design of the HAI-HF Trial
Background:
Heart failure with reduced ejection fraction (HFrEF) is a heterogeneous condition with variable potential for left ventricular ejection fraction (LVEF) recovery. While LVEF improvement and reverse remodeling predict better outcomes, the determinants that predict left ventricular recovery remain poorly understood. An expert panel of the Journal of American College of Cardiology highlighted the need for improved HFrEF phenotyping to clarify recovery patterns and support personalized management and risk stratification.
Read more
Methods:
PRIMA-HF is a prospective prediction study designed to determine whether baseline cardiac multimodality imaging can predict LVEF recovery in patients with de novo HFrEF (n=180). The imaging protocol includes cardiac magnetic resonance (CMR), coronary computed tomography and [¹⁵O]H₂O positron emission tomography ([¹⁵O]H₂O-PET) and echocardiography. Patients will also undergo a six-minute walk test, blood volume measurement, and blood sampling. The primary outcome is the change in LVEF from baseline to approx. after 3-12 months (or after full optitration in GDMT), assessed by CMR.
In 60 patients from the PRIMA-HF cohort, the randomized, double-blind study High Dose Adenosine During Perfusion Imaging in Heart Failure (HAI-HF) will be conducted. HAI-HF evaluates whether high-dose adenosine (210 µg/kg/min) versus standard-dose (140 µg/kg/min) during [¹⁵O]H₂O-PET changes the stress myocardial blood flow, which is the primary endpoint.
Aim:
The PRIMA-HF study comprehensively characterizes patients with newly diagnosed HFrEF through multimodality imaging and systematically assesses change in LVEF using CMR. The study's deep phenotyping approach integrates clinical, imaging, biomarker, and functional data to capture disease heterogeneity, rather than relying on traditional measures such as LVEF or symptom class. This enables the identification of distinct patient subgroups with shared pathophysiological mechanisms.
The HAI-HF trial examines whether higher adenosine doses improve [¹⁵O]H₂O-PET perfusion imaging in HFrEF.
Together, the studies will advance understanding of myocardial recovery, improve perfusion assessment, and support development of a predictive model for HFrEF prognosis.
- Being tested
- HAI-HF: Adenosine Stress [¹⁵O]H₂O PET Imaging, Two different doses of adenosine
- Keywords
- LVEF, HFrEF, HFrecEF, Perfusion Imaging, Adenosine, Cardiac Magnetic Resonance Imaging
- Medical subject headings
- Heart Failure, Systolic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAI-HF: Adenosine Stress [¹⁵O]H₂O PET ImagingDiagnostic test
HAI-HF: Patients will be randomized in a 1:1 ratio to one of two dosing sequences: high-dose followed by low-dose adenosine, or low-dose followed by high-dose adenosine.
Two different doses of adenosineDrug
Testing if high dose adenosine (210 ug/kg/min) during perfusion imaging results in a higher myocardial blood flow compared to standard dose (140 ug/kg/min) in patients with HFrEF
| Study group | Role | What they receive |
|---|---|---|
| Low-dose then High-dose Adenosine | Experimental | Not described Receives: Diagnostic Test: HAI-HF: Adenosine Stress [¹⁵O]H₂O PET Imaging; Drug: Two different doses of adenosine |
| High-dose then Low-dose Adenosine | Experimental | Not described Receives: Diagnostic Test: HAI-HF: Adenosine Stress [¹⁵O]H₂O PET Imaging; Drug: Two different doses of adenosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
PRIMA-HF: Left ventricular ejection fraction (LVEF)
Change in LVEF (continuous variable, absolute change in LVEF in percent points)
Measured: PRIMA-HF: Baseline through study completion, an average of 3 months
HAI-HF: Stress Myocardial Blood Flow (MBF)
Change in stress MBF (continuous variable, ml/min/g)
Measured: Baseline and periprocedural
Secondary outcomes (2)
PRIMA-HF: Kansas City Cardiomyopathy Questionaire (KCCQ-12)
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ-12) (points, continuous data)
Measured: Baseline through study completion, an average of 3 months
PRIMA-HF: 6 minutes-walk-test
Change in 6MWT distance (meters, continuous data)
Measured: Baseline through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start8 Dec 2025
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Heart Failure and Reduced Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gødstrup Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Lindhøj Kvorning, Gødstrup Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243119
- Sponsor's protocol ID
- 1-10-72-126-25
- Acronym
- PRIMA-HF
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study will adhere to all applicable regulations and guidelines governing the transfer of individual participantdata (IPD), which will be biological material (blood samples), abroad, ensuring that all data are handled confidentially and in full compliance with relevant legislation.
Publications
Funaya H, Kitakaze M, Node K, Minamino T, Komamura K, Hori M. Plasma adenosine levels increase in patients with chronic heart failure. Circulation. 1997 Mar 18;95(6):1363-5. doi: 10.1161/01.cir.95.6.1363.
PubMed 9118500Kim IC, Yoo BS. Multidimensional Approach of Heart Failure Diagnosis and Prognostication Utilizing Cardiac Imaging with Biomarkers. Diagnostics (Basel). 2022 Jun 1;12(6):1366. doi: 10.3390/diagnostics12061366.
PubMed 35741176Wilcox J, Yancy CW. Stopping medication for heart failure with improved ejection fraction. Lancet. 2019 Jan 5;393(10166):8-10. doi: 10.1016/S0140-6736(18)32825-3. Epub 2018 Nov 11. No abstract available.
PubMed 30429051Wilcox JE, Fang JC, Margulies KB, Mann DL. Heart Failure With Recovered Left Ventricular Ejection Fraction: JACC Scientific Expert Panel. J Am Coll Cardiol. 2020 Aug 11;76(6):719-734. doi: 10.1016/j.jacc.2020.05.075.
PubMed 32762907Postnov DD, Tuchin VV, Sosnovtseva O. Estimation of vessel diameter and blood flow dynamics from laser speckle images. Biomed Opt Express. 2016 Jun 22;7(7):2759-68. doi: 10.1364/BOE.7.002759. eCollection 2016 Jul 1.
PubMed 27446704Borges JP, Lopes GO, Verri V, Coelho MP, Nascimento PM, Kopiler DA, Tibirica E. A novel effective method for the assessment of microvascular function in male patients with coronary artery disease: a pilot study using laser speckle contrast imaging. Braz J Med Biol Res. 2016 Sep 1;49(10):e5541. doi: 10.1590/1414-431X20165541.
PubMed 27599202Strobeck JE, Feldschuh J, Miller WL. Heart Failure Outcomes With Volume-Guided Management. JACC Heart Fail. 2018 Nov;6(11):940-948. doi: 10.1016/j.jchf.2018.06.017. Epub 2018 Oct 10.
PubMed 30316941Bello D, Shah DJ, Farah GM, Di Luzio S, Parker M, Johnson MR, Cotts WG, Klocke FJ, Bonow RO, Judd RM, Gheorghiade M, Kim RJ. Gadolinium cardiovascular magnetic resonance predicts reversible myocardial dysfunction and remodeling in patients with heart failure undergoing beta-blocker therapy. Circulation. 2003 Oct 21;108(16):1945-53. doi: 10.1161/01.CIR.0000095029.57483.60. Epub 2003 Oct 13.
PubMed 14557364Dewey M, Siebes M, Kachelriess M, Kofoed KF, Maurovich-Horvat P, Nikolaou K, Bai W, Kofler A, Manka R, Kozerke S, Chiribiri A, Schaeffter T, Michallek F, Bengel F, Nekolla S, Knaapen P, Lubberink M, Senior R, Tang MX, Piek JJ, van de Hoef T, Martens J, Schreiber L; Quantitative Cardiac Imaging Study Group. Clinical quantitative cardiac imaging for the assessment of myocardial ischaemia. Nat Rev Cardiol. 2020 Jul;17(7):427-450. doi: 10.1038/s41569-020-0341-8. Epub 2020 Feb 24.
PubMed 32094693Tersalvi G, Beltrani V, Grubler MR, Molteni A, Cristoforetti Y, Pedrazzini G, Treglia G, Biasco L. Positron Emission Tomography in Heart Failure: From Pathophysiology to Clinical Application. J Cardiovasc Dev Dis. 2023 May 17;10(5):220. doi: 10.3390/jcdd10050220.
PubMed 37233187Graversen CB, Rasmussen LD, Sundboll J, Wurtz M, Kragholm KH, Bottcher M, Winther S. Cardiac computed tomography for rule-out of ischaemic heart disease in patients with new-onset heart failure. Eur Heart J Cardiovasc Imaging. 2025 Apr 30;26(5):794-801. doi: 10.1093/ehjci/jeaf090.
PubMed 40085773Burger PM, Savarese G, Tromp J, Adamson C, Jhund PS, Benson L, Hage C, Tay WT, Solomon SD, Packer M, Rossello X, McEvoy JW, De Bacquer D, Timmis A, Vardas P, Graham IM, Di Angelantonio E, Visseren FLJ, McMurray JJV, Lam CSP, Lund LH, Koudstaal S, Dorresteijn JAN, Mosterd A; European Society of Cardiology's Cardiovascular Risk Collaboration (ESC CRC). Personalized lifetime prediction of survival and treatment benefit in patients with heart failure with reduced ejection fraction: The LIFE-HF model. Eur J Heart Fail. 2023 Nov;25(11):1962-1975. doi: 10.1002/ejhf.3028. Epub 2023 Sep 18.
PubMed 37691140Perera D, Clayton T, O'Kane PD, Greenwood JP, Weerackody R, Ryan M, Morgan HP, Dodd M, Evans R, Canter R, Arnold S, Dixon LJ, Edwards RJ, De Silva K, Spratt JC, Conway D, Cotton J, McEntegart M, Chiribiri A, Saramago P, Gershlick A, Shah AM, Clark AL, Petrie MC; REVIVED-BCIS2 Investigators. Percutaneous Revascularization for Ischemic Left Ventricular Dysfunction. N Engl J Med. 2022 Oct 13;387(15):1351-1360. doi: 10.1056/NEJMoa2206606. Epub 2022 Aug 27.
PubMed 36027563Kjaerulff MLG, Tolbod LP, Pryds K, Nielsen R, Madsen S, Luong TV, Gormsen LC. Clinical use of [15O]H2O/[18F]FDG viability positron emission tomography does not reliably predict left ventricular ejection fraction improvement or survival after revascularization. Eur Heart J Cardiovasc Imaging. 2025 May 30;26(6):969-979. doi: 10.1093/ehjci/jeaf041.
PubMed 39901814Basuray A, French B, Ky B, Vorovich E, Olt C, Sweitzer NK, Cappola TP, Fang JC. Heart failure with recovered ejection fraction: clinical description, biomarkers, and outcomes. Circulation. 2014 Jun 10;129(23):2380-7. doi: 10.1161/CIRCULATIONAHA.113.006855. Epub 2014 May 5.
PubMed 24799515
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRIMA-HF PRedicting Recovery of Left Ventricular Function With Multimodality Cardiac IMAging in Patients With de Novo Heart Failure HAI-HF: High-Dose Adenosine During Perfusion Imaging in Heart Failure: Rationale and Design of the HAI-HF Trial
- ClinicalTrials.gov ID
- NCT07243119
- Acronym / sponsor ID
- PRIMA-HF / 1-10-72-126-25
- Keywords
- LVEF, HFrEF, HFrecEF, Perfusion Imaging, Adenosine, Cardiac Magnetic Resonance Imaging
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Gødstrup HospitalUniversity, hospital or other
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Heart failure with reduced ejection fraction (HFrEF) is a heterogeneous condition with variable potential for left ventricular ejection fraction (LVEF) recovery. While LVEF improvement and reverse remodeling predict better outcomes, the determinants that predict left ventricular recovery remain poorly understood. An expert panel of the Journal of American College of Cardiology highlighted the need for improved HFrEF phenotyping to clarify recovery patterns and support personalized management and risk stratification.
Methods:
PRIMA-HF is a prospective prediction study designed to determine whether baseline cardiac multimodality imaging can predict LVEF recovery in patients with de novo HFrEF (n=180). The imaging protocol includes cardiac magnetic resonance (CMR), coronary computed tomography and [¹⁵O]H₂O positron emission tomography ([¹⁵O]H₂O-PET) and echocardiography. Patients will also undergo a six-minute walk test, blood volume measurement, and blood sampling. The primary outcome is the change in LVEF from baseline to approx. after 3-12 months (or after full optitration in GDMT), assessed by CMR.
In 60 patients from the PRIMA-HF cohort, the randomized, double-blind study High Dose Adenosine During Perfusion Imaging in Heart Failure (HAI-HF) will be conducted. HAI-HF evaluates whether high-dose adenosine (210 µg/kg/min) versus standard-dose (140 µg/kg/min) during [¹⁵O]H₂O-PET changes the stress myocardial blood flow, which is the primary endpoint.
Aim:
The PRIMA-HF study comprehensively characterizes patients with newly diagnosed HFrEF through multimodality imaging and systematically assesses change in LVEF using CMR. The study's deep phenotyping approach integrates clinical, imaging, biomarker, and functional data to capture disease heterogeneity, rather than relying on traditional measures such as LVEF or symptom class. This enables the identification of distinct patient subgroups with shared pathophysiological mechanisms.
The HAI-HF trial examines whether higher adenosine doses improve [¹⁵O]H₂O-PET perfusion imaging in HFrEF.
Together, the studies will advance understanding of myocardial recovery, improve perfusion assessment, and support development of a predictive model for HFrEF prognosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dose then High-dose Adenosine | Experimental | Diagnostic Test: HAI-HF: Adenosine Stress [¹⁵O]H₂O PET Imaging, Drug: Two different doses of adenosine |
| High-dose then Low-dose Adenosine | Experimental | Diagnostic Test: HAI-HF: Adenosine Stress [¹⁵O]H₂O PET Imaging, Drug: Two different doses of adenosine |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Capable and has provided written informed consent
- LVEF ≤ 40% by echocardiography in connection with hospitalization for heart failure or in connection with outpatient evaluation for heart failure
Key exclusion criteria (14 listed)
- Previous diagnosis of heart failure
- Unable to understand the patient information
- Pregnancy, as the study involves ionizing radiation.
- Current severe valvular disease (as defined by the Danish national treatment guidelines on cardio.dk)
- Atrial fibrillation with a heart rate > 130 beats per minute during the inclusion echocardiography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HAI-HF: Adenosine Stress [¹⁵O]H₂O PET ImagingHAI-HF: Patients will be randomized in a 1:1 ratio to one of two dosing sequences: high-dose followed by low-dose adenosine, or low-dose followed by high-dose adenosine. | Diagnostic test | High-dose then Low-dose Adenosine, Low-dose then High-dose Adenosine |
| Two different doses of adenosineTesting if high dose adenosine (210 ug/kg/min) during perfusion imaging results in a higher myocardial blood flow compared to standard dose (140 ug/kg/min) in patients with HFrEF | Drug | High-dose then Low-dose Adenosine, Low-dose then High-dose Adenosine |
Primary outcome
PRIMA-HF: Left ventricular ejection fraction (LVEF)
Time frame: PRIMA-HF: Baseline through study completion, an average of 3 months
Change in LVEF (continuous variable, absolute change in LVEF in percent points)
HAI-HF: Stress Myocardial Blood Flow (MBF)
Time frame: Baseline and periprocedural
Change in stress MBF (continuous variable, ml/min/g)
2 secondary outcomes
PRIMA-HF: Kansas City Cardiomyopathy Questionaire (KCCQ-12)
Time frame: Baseline through study completion, an average of 3 months
PRIMA-HF: 6 minutes-walk-test
Time frame: Baseline through study completion, an average of 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Background: PubMed 9118500Funaya H, Kitakaze M, Node K, Minamino T, Komamura K, Hori M. Plasma adenosine levels increase in patients with chronic heart failure. Circulation. 1997 Mar 18;95(6):1363-5. doi: 10.1161/01.cir.95.6.1363.
- Background: PubMed 35741176Kim IC, Yoo BS. Multidimensional Approach of Heart Failure Diagnosis and Prognostication Utilizing Cardiac Imaging with Biomarkers. Diagnostics (Basel). 2022 Jun 1;12(6):1366. doi: 10.3390/diagnostics12061366.
- Background: PubMed 30429051Wilcox J, Yancy CW. Stopping medication for heart failure with improved ejection fraction. Lancet. 2019 Jan 5;393(10166):8-10. doi: 10.1016/S0140-6736(18)32825-3. Epub 2018 Nov 11. No abstract available.
- Background: PubMed 32762907Wilcox JE, Fang JC, Margulies KB, Mann DL. Heart Failure With Recovered Left Ventricular Ejection Fraction: JACC Scientific Expert Panel. J Am Coll Cardiol. 2020 Aug 11;76(6):719-734. doi: 10.1016/j.jacc.2020.05.075.
- Background: PubMed 27446704Postnov DD, Tuchin VV, Sosnovtseva O. Estimation of vessel diameter and blood flow dynamics from laser speckle images. Biomed Opt Express. 2016 Jun 22;7(7):2759-68. doi: 10.1364/BOE.7.002759. eCollection 2016 Jul 1.
- Background: PubMed 27599202Borges JP, Lopes GO, Verri V, Coelho MP, Nascimento PM, Kopiler DA, Tibirica E. A novel effective method for the assessment of microvascular function in male patients with coronary artery disease: a pilot study using laser speckle contrast imaging. Braz J Med Biol Res. 2016 Sep 1;49(10):e5541. doi: 10.1590/1414-431X20165541.
- Background: PubMed 30316941Strobeck JE, Feldschuh J, Miller WL. Heart Failure Outcomes With Volume-Guided Management. JACC Heart Fail. 2018 Nov;6(11):940-948. doi: 10.1016/j.jchf.2018.06.017. Epub 2018 Oct 10.
- Background: PubMed 14557364Bello D, Shah DJ, Farah GM, Di Luzio S, Parker M, Johnson MR, Cotts WG, Klocke FJ, Bonow RO, Judd RM, Gheorghiade M, Kim RJ. Gadolinium cardiovascular magnetic resonance predicts reversible myocardial dysfunction and remodeling in patients with heart failure undergoing beta-blocker therapy. Circulation. 2003 Oct 21;108(16):1945-53. doi: 10.1161/01.CIR.0000095029.57483.60. Epub 2003 Oct 13.
- Background: PubMed 32094693Dewey M, Siebes M, Kachelriess M, Kofoed KF, Maurovich-Horvat P, Nikolaou K, Bai W, Kofler A, Manka R, Kozerke S, Chiribiri A, Schaeffter T, Michallek F, Bengel F, Nekolla S, Knaapen P, Lubberink M, Senior R, Tang MX, Piek JJ, van de Hoef T, Martens J, Schreiber L; Quantitative Cardiac Imaging Study Group. Clinical quantitative cardiac imaging for the assessment of myocardial ischaemia. Nat Rev Cardiol. 2020 Jul;17(7):427-450. doi: 10.1038/s41569-020-0341-8. Epub 2020 Feb 24.
- Background: PubMed 37233187Tersalvi G, Beltrani V, Grubler MR, Molteni A, Cristoforetti Y, Pedrazzini G, Treglia G, Biasco L. Positron Emission Tomography in Heart Failure: From Pathophysiology to Clinical Application. J Cardiovasc Dev Dis. 2023 May 17;10(5):220. doi: 10.3390/jcdd10050220.
- Background: PubMed 40085773Graversen CB, Rasmussen LD, Sundboll J, Wurtz M, Kragholm KH, Bottcher M, Winther S. Cardiac computed tomography for rule-out of ischaemic heart disease in patients with new-onset heart failure. Eur Heart J Cardiovasc Imaging. 2025 Apr 30;26(5):794-801. doi: 10.1093/ehjci/jeaf090.
- Background: PubMed 37691140Burger PM, Savarese G, Tromp J, Adamson C, Jhund PS, Benson L, Hage C, Tay WT, Solomon SD, Packer M, Rossello X, McEvoy JW, De Bacquer D, Timmis A, Vardas P, Graham IM, Di Angelantonio E, Visseren FLJ, McMurray JJV, Lam CSP, Lund LH, Koudstaal S, Dorresteijn JAN, Mosterd A; European Society of Cardiology's Cardiovascular Risk Collaboration (ESC CRC). Personalized lifetime prediction of survival and treatment benefit in patients with heart failure with reduced ejection fraction: The LIFE-HF model. Eur J Heart Fail. 2023 Nov;25(11):1962-1975. doi: 10.1002/ejhf.3028. Epub 2023 Sep 18.
- Individual participant dataSharing planned: Yes. The study will adhere to all applicable regulations and guidelines governing the transfer of individual participantdata (IPD), which will be biological material (blood samples), abroad, ensuring that all data are handled confidentially and in full compliance with relevant legislation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing HAI-HF: Adenosine Stress [¹⁵O]H₂O PET Imaging and Two different doses of adenosine in people with Heart Failure and Reduced Ejection Fraction and Heart Failure, run by Gødstrup Hospital at 1 site in Denmark.
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 3 inclusion and 14 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: enrolling by invitation, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
PRIMA-HF: Left ventricular ejection fraction (LVEF) (time frame: PRIMA-HF: Baseline through study completion, an average of 3 months). The study lists 2 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 NCT07243119, which also lists 23 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 26 Dec 2025.