HF - Heart FailureFERRIFYNCT05750940
Oxidative Skeletal Muscle Metabolism in Chronic Heart Failure Patients With and Without Iron Deficiency
An observational study of HF - Heart Failure and Iron-deficiency, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Observational study using in vivo noninvasive 31 phosphor magnetic resonance spectroscopy (31P MRS) to quantify the effect of iron deficiency (ID) on skeletal oxidative metabolism in patients with chronic heart failure (HF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HF - Heart Failure, Iron-deficiency
- What is being tested?
- 31Phosphor Magnetic Resonance Spectroscopy
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Oct 2021to 1 May 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: For this study, we will include 40 non-anaemic patients with stable chronic HF, subdivided in 20 patients with HFrEF and 20 subjects with HFrEF. HFpEF and HFrEF patients will be further subdivided into 10 patients with ID and 10 patients without ID. These patients will be recruited from the outpatient clinic of the Department of Cardiology, UMCG. Patients must be stable at the time of inclusion (i.e. no medication changes <1 month prior to study).
Who may be able to join
- For HFrEF patients:
- Diagnosis of chronic HF of either ischemic or non-ischemic etiology;
- Stable, evidence-based medical therapy for HF;
- LVEF <40% measured <5 year prior to inclusion;
- NYHA class II - III (symptomatic HF) at moment of inclusion;
- For HFpEF patients:
Show all 16Show fewer
- Diagnosis of chronic HF of either ischemic or non-ischemic etiology;
- LVEF >40% and one of the following parameters, measured <5 year prior to inclusion;
- Left atrial volume index (LAVI) >34 mL/m2 or
- left ventricular mass index ≥115 g/m2 (for males) or ≥95 g/m2 (for females) or
- E/e' ≥13 or
- mean e' (septal and lateral) <9 cm/s
- NYHA class II - III (symptomatic HF) at moment of inclusion;
- Serum NT-proBNP ≥125 pg/mL when in sinus rhythm; >300 pg/mL when in atrial fibrillation.
- Additional inclusion criterion for subjects with ID:
- Iron deficiency, defined as TSAT <20%.
Who cannot join
- Age <18 years;
- Unable or unwilling to undergo exercise MRI (e.g. pregnancy, physical disabilities, claustrophobia);
- The presence of ferromagnetic material in/on the body which cannot be removed (e.g. non-MRI-compatible cardiac devices, tattoos containing ferrous ink);
- History of erythropoietin stimulating agent, intravenous iron therapy and/or blood transfusion <3 months prior to study enrolment;
- Moderate anaemia, defined as Hb <7 mmol/L for both men and women;
- Oral iron therapy >100 mg/day <4 weeks prior to study enrolment;
- Unable to understand study procedures;
- Unable or unwilling to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Observational study using in vivo noninvasive 31 phosphor magnetic resonance spectroscopy (31P MRS) to quantify the effect of iron deficiency (ID) on skeletal oxidative metabolism in patients with chronic heart failure (HF).
Read the detailed description
Iron Deficiency (ID) is a comorbidity in heart failure (HF) patients with high prevalence and severe clinical consequences. Multiple studies have shown that ID in HF patients impairs exercise capacity, quality of life and outcome. It is currently unknown whether these detrimental consequences of ID are due to cardiovascular or hematologic effects, or deteriorated peripheral muscle metabolism and function. This study was designed to quantify the effect of ID on skeletal oxidative metabolism in patients with chronic HF.
- Conditions
- HF - Heart Failure, Iron-deficiency
- Being tested
- 31Phosphor Magnetic Resonance Spectroscopy
- Keywords
- 31P MRS, 31Phosphor Magnetic Resonance Spectroscopy, HFpEF, HFrEF, Oxidative Skeletal Muscle Metabolism
- Medical subject headings
- Heart Failure, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
31Phosphor Magnetic Resonance SpectroscopyDiagnostic test
Measurement of skeletal oxidative metabolism with 31phosphor magnetic resonance spectroscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
ΔPi/PCr from baseline to maximum exercise
Δ ratio of inorganic phosphate/Phosphocreatinin concentrations from baseline to maximum exercise
Measured: During study visit, from resting baseline to maximum exercise (from start exercise upto exhaustion for a maximum timeframe of 10 minutes)
Secondary outcomes (3)
PCr recovery rate during recovery
Post-exercise phosphocreatinin recovery rate
Measured: During study visit, from maximum exercise to end of recovery (upto at least 5 minutes after end of exercise)
Intramuscular pH
Rates and magnitude of change in intramuscular pH during exercise
Measured: During study visit, during exercise (from start exercise upto exhaustion for a maximum timeframe of 10 minutes)
Maximal exercise performance
Maximal exercise performance
Measured: During study visit, during exercise (from start exercise upto exhaustion for a maximum timeframe of 10 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start5 Oct 2021
- Primary completion1 Apr 2023 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HF - Heart FailureStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter van der Meer, MD PhD, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750940
- Sponsor's protocol ID
- 201700917
- Acronym
- FERRIFY
- Status last verified
- Feb 2023
- First submitted
- 5 Oct 2021
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Weerts J, Voorrips SN, Jeneson JAL, Barandiaran Aizpurua A, Mevenkamp J, Sibeijn-Kuiper AJ, Renken RJ, Schroen BLM, Knackstedt C, Houben AJHM, Van der Meer P, Schrauwen-Hinderling VB, Westenbrink BD, van Empel VPM. Quantifying skeletal muscle energy metabolism during exercise in heart failure with preserved ejection fraction using in vivo 31P magnetic resonance spectroscopy. ESC Heart Fail. 2026 Mar 3;13(2):xvaf035. doi: 10.1093/eschf/xvaf035.
PubMed 41914778
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxidative Skeletal Muscle Metabolism in Chronic Heart Failure Patients With and Without Iron Deficiency
- ClinicalTrials.gov ID
- NCT05750940
- Acronym / sponsor ID
- FERRIFY / 201700917
- Conditions
- HF - Heart Failure, Iron-deficiency
- Keywords
- 31P MRS, 31Phosphor Magnetic Resonance Spectroscopy, HFpEF, HFrEF, Oxidative Skeletal Muscle Metabolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 2 Mar 2023 (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.
Observational study using in vivo noninvasive 31 phosphor magnetic resonance spectroscopy (31P MRS) to quantify the effect of iron deficiency (ID) on skeletal oxidative metabolism in patients with chronic heart failure (HF).
Detailed description
Iron Deficiency (ID) is a comorbidity in heart failure (HF) patients with high prevalence and severe clinical consequences. Multiple studies have shown that ID in HF patients impairs exercise capacity, quality of life and outcome. It is currently unknown whether these detrimental consequences of ID are due to cardiovascular or hematologic effects, or deteriorated peripheral muscle metabolism and function. This study was designed to quantify the effect of ID on skeletal oxidative metabolism in patients with chronic HF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For this study, we will include 40 non-anaemic patients with stable chronic HF, subdivided in 20 patients with HFrEF and 20 subjects with HFrEF. HFpEF and HFrEF patients will be further subdivided into 10 patients with ID and 10 patients without ID. These patients will be recruited from the outpatient clinic of the Department of Cardiology, UMCG. Patients must be stable at the time of inclusion (i.e. no medication changes <1 month prior to study).
Key inclusion criteria (16 listed)
- Diagnosis of chronic HF of either ischemic or non-ischemic etiology;
- Stable, evidence-based medical therapy for HF;
- LVEF <40% measured <5 year prior to inclusion;
- NYHA class II - III (symptomatic HF) at moment of inclusion;
- Diagnosis of chronic HF of either ischemic or non-ischemic etiology;
Key exclusion criteria (8 listed)
- Age <18 years;
- Unable or unwilling to undergo exercise MRI (e.g. pregnancy, physical disabilities, claustrophobia);
- The presence of ferromagnetic material in/on the body which cannot be removed (e.g. non-MRI-compatible cardiac devices, tattoos containing ferrous ink);
- History of erythropoietin stimulating agent, intravenous iron therapy and/or blood transfusion <3 months prior to study enrolment;
- Moderate anaemia, defined as Hb <7 mmol/L for both men and women;
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 |
|---|---|---|
| 31Phosphor Magnetic Resonance SpectroscopyMeasurement of skeletal oxidative metabolism with 31phosphor magnetic resonance spectroscopy | Diagnostic test | – |
Primary outcome
ΔPi/PCr from baseline to maximum exercise
Time frame: During study visit, from resting baseline to maximum exercise (from start exercise upto exhaustion for a maximum timeframe of 10 minutes)
Δ ratio of inorganic phosphate/Phosphocreatinin concentrations from baseline to maximum exercise
3 secondary outcomes
PCr recovery rate during recovery
Time frame: During study visit, from maximum exercise to end of recovery (upto at least 5 minutes after end of exercise)
Intramuscular pH
Time frame: During study visit, during exercise (from start exercise upto exhaustion for a maximum timeframe of 10 minutes)
Maximal exercise performance
Time frame: During study visit, during exercise (from start exercise upto exhaustion for a maximum timeframe of 10 minutes)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Derived from this study: PubMed 41914778Weerts J, Voorrips SN, Jeneson JAL, Barandiaran Aizpurua A, Mevenkamp J, Sibeijn-Kuiper AJ, Renken RJ, Schroen BLM, Knackstedt C, Houben AJHM, Van der Meer P, Schrauwen-Hinderling VB, Westenbrink BD, van Empel VPM. Quantifying skeletal muscle energy metabolism during exercise in heart failure with preserved ejection fraction using in vivo 31P magnetic resonance spectroscopy. ESC Heart Fail. 2026 Mar 3;13(2):xvaf035. doi: 10.1093/eschf/xvaf035.
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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. This study is not recruiting at the moment.
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?
An observational study of HF - Heart Failure and Iron-deficiency, run by University Medical Center Groningen at 1 site in Netherlands.
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 16 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 2 Mar 2023. 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 Netherlands. 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.
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?
ΔPi/PCr from baseline to maximum exercise (time frame: During study visit, from resting baseline to maximum exercise (from start exercise upto exhaustion for a maximum timeframe of 10 minutes)). 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 NCT05750940, which also lists 1 linked publication.
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 2 Mar 2023.