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
NCT ID: NCT07243119
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE4
180 participants
INTERVENTIONAL
2025-12-08
2029-04-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
QUADRUPLE
Study Groups
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Low-dose then High-dose Adenosine
HAI-HF: Adenosine Stress [¹⁵O]H₂O PET Imaging
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 adenosine
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
High-dose then Low-dose Adenosine
HAI-HF: Adenosine Stress [¹⁵O]H₂O PET Imaging
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 adenosine
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
Interventions
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HAI-HF: Adenosine Stress [¹⁵O]H₂O PET Imaging
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 adenosine
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
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
100 Years
ALL
No
Sponsors
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Gødstrup Hospital
OTHER
Responsible Party
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Sarah Lindhøj Kvorning
Principal Investigator, MD, PhD student
Locations
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University Clinic of Cardiovascular Reseach
Herning, , Denmark
Countries
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References
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Other Identifiers
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1-10-72-126-25
Identifier Type: -
Identifier Source: org_study_id