Heart FailurePhase 2NEAT-HFpeFNCT02053493
Nitrate's Effect on Activity Tolerance in Heart Failure With Preserved Ejection Fraction
A Phase 2 study testing Isosorbide Mononitrate in people with Heart Failure, run by Adrian Hernandez at 22 sites in United States.
Trial summary
A randomized, double-blinded, placebo-controlled crossover study to assess effect of isosorbide mononitrate with dose up-titration on activity tolerance as assessed by (hip-worn, tri-axial) accelerometry. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Isosorbide Mononitrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 22 sitesUnited States
- Study dates
- Apr 2014to Mar 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 50 years
- Symptoms of dyspnea (NYHA class II-IV) without evidence of a non-cardiac or ischemic explanation for dyspnea
- Ejection fraction (EF) ≥ 50% as determined on imaging study within 12 months of enrollment with no change in clinical status suggesting potential for deterioration in systolic function
- Stable medical therapy for 30 days as defined by:
- No addition or removal of ACE, Angiotensin receptor blockers (ARBs), beta-blockers, calcium channel blockers (CCBs) or aldosterone antagonists
- No change in dosage of ACE, ARBs, beta-blockers,CCBs or aldosterone antagonists of more than 100%
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- One of the following within the last 12 months
- Previous hospitalization for heart failure (HF) with radiographic evidence of pulmonary congestion (pulmonary venous hypertension, vascular congestion, interstitial edema, pleural effusion) or
- Catheterization documented elevated filling pressures at rest (LVEDP≥15 or PCWP≥20) or with exercise (PCWP≥25) or
- Elevated NT-proBNP (> 400 pg/ml) or BNP (> 200 pg/ml) or
- Echo evidence of diastolic dysfunction / elevated filling pressures (at least two) E/A > 1.5 + decrease in E/A of > 0.5 with valsalva Deceleration time ≤ 140 ms Pulmonary vein velocity in systole < diastole (PVs<PVd)sinus rhythm) E/e'≥15 Left atrial enlargement (≥ moderate) Pulmonary artery systolic pressure > 40 mmHg Evidence of left ventricular hypertrophy
- LV mass/BSA ≥ 96 (♀) or ≥ 116 (♂) g/m2
- Relative wall thickness ≥ 0.43 (♂ or ♀) [(IVS+PW)/LVEDD]
- Posterior wall thickness ≥ 0.9 (♀) or 1.0 (♂) cm
- No chronic nitrate therapy or infrequent (≤ 1x week) use of intermittent sublingual nitroglycerin within last 3 months
- Ambulatory (not wheelchair / scooter / walker / cane dependent)
- HF is the primary factor limiting activity as indicated by answering # 2 to the following question:
- My ability to be active is most limited by:
- Joint, foot, leg, hip or back pain
- Shortness of breath and/or fatigue and/or chest pain
- Unsteadiness or dizziness
- Lifestyle, weather, or I just don't like to be active
- 9. Body size allows wearing of the accelerometer belt as confirmed by ability to comfortably fasten the test belt provided for the screening process (belt designed to fit persons with BMI 20-40 Kg/m2 but belt may fit some persons outside this range)
- 10. Willingness to wear the accelerometer belt for the duration of the trial 11. Willingness to provide informed consent
Who cannot join
- Recent (< 3 months) hospitalization for HF
- Hemoglobin < 8.0 g/dl
- Glomerular filtration rate < 20 ml/min/1.73 m2 on most recent clinical laboratories
- SBP < 110 mmHg or > 180 mmHg at consent
- Diastolic blood pressure < 40 mmHg or > 100 mmHg at consent
- Resting HR > 110 bpm at consent
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- Previous adverse reaction to nitrates necessitating withdrawal of therapy
- Chronic therapy with phosphodiesterase type-5 inhibitors (intermittent use of phosphodiesterase type-5 inhibitors for erectile dysfunction is allowable if the patient is willing to hold for the duration of the trial)
- Regularly (> 1x per week) swims or does water aerobics
- Significant COPD thought to contribute to dyspnea
- Ischemia thought to contribute to dyspnea
- Documentation of previous EF < 50%
- Acute coronary syndrome within 3 months defined by electrocardiographic changes and biomarkers of myocardial necrosis (e.g. troponin) in an appropriate clinical setting (chest discomfort or anginal equivalent)
- Percutaneous coronary intervention, coronary artery bypass grafting or new biventricular pacing within past 3 months
- Primary hypertrophic cardiomyopathy
- Infiltrative cardiomyopathy (amyloid)
- Constrictive pericarditis or tamponade
- Active myocarditis
- Complex congenital heart disease
- Active collagen vascular disease
- More than mild aortic or mitral stenosis
- Intrinsic (prolapse, rheumatic) valve disease with moderate to severe or severe mitral, tricuspid or aortic regurgitation
- Acute or chronic severe liver disease as evidenced by any of the following: encephalopathy, variceal bleeding, INR > 1.7 in the absence of anticoagulation treatment
- Terminal illness (other than HF) with expected survival of less than 1 year
- Enrollment or planned enrollment in another therapeutic clinical trial in the next 3 months
- Inability to comply with planned study procedures
- Pregnant women
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Emory University School of Medicine
Atlanta, Georgia, 30322
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Tufts Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
The University of Vermont - Fletcher Allen Health Care
Burlington, Vermont, 05401
Northwestern University
Chicago, Illinois, 60611
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Metro Health System
Cleveland, Ohio, 44109
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Duke University Medical Center
Durham, North Carolina, 27705
Michael E Debakey VA Medical Center
Houston, Texas, 77030
Lancaster General Hospital
Lancaster, Pennsylvania, 17604
Christiana Care Health Services
Newark, Delaware, 19718
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
Jefferson Medical College
Philadelphia, Pennsylvania, 19107
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Mayo Clinic
Rochester, Minnesota, 55905
University of Utah Hospitals and Clinics
Salt Lake City, Utah, 84132
V.A. Medical Center
Salt Lake City, Utah, 84148
Washington University School of Medicine
St Louis, Missouri, 63110
Boston V.A. Healthcare System
West Roxbury, Massachusetts, 02132
About this study
A randomized, double-blinded, placebo-controlled crossover study to assess effect of isosorbide mononitrate with dose up-titration on activity tolerance as assessed by (hip-worn, tri-axial) accelerometry.
Read the detailed description
To evaluate whether isosorbide mononitrate increases daily activity as assessed by 14-day averaged arbitrary accelerometry units in comparison to placebo.
- Conditions
- Heart Failure
- Being tested
- Isosorbide Mononitrate, Placebo
- Keywords
- Heart Failure, Preserved Ejection Fraction
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isosorbide MononitrateDrug
Also called Imdur, ISMO, Monoket
Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN
PlaceboDrug
Dispense phase 1 study drug:
Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo
Dispense phase-2 study drug:
Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo
| Study group | Role | What they receive |
|---|---|---|
| Isosorbide Mononitrate | Active comparator | Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks) Receives: Drug: Isosorbide Mononitrate |
| Isosorbide Mononitate Placebo | Placebo comparator | Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arbitrary Accelerometry Units (AAU) (Phase I)
To evaluate whether isosorbide mononitrate increases daily activity as assessed by 14-day averaged arbitrary accelerometry units in comparison to placebo. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement.
Measured: 5-6 weeks
Arbitrary Accelerometry Units (AAU) (Phase II)
To evaluate whether isosorbide mononitrate increases daily activity as assessed by 14-day averaged arbitrary accelerometry units in comparison to placebo. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement.
Measured: 11-12 weeks
Secondary outcomes (15)
Six Minute Walk Distance (Phase I)
To evaluate whether isosorbide mononitrate (ISMN) improves functional capacity by 6 minute walk distance in comparison to placebo.
Measured: Week 7
Six Minute Walk Distance (Phase II)
To evaluate whether isosorbide mononitrate (ISMN) improves functional capacity by 6 minute walk distance in comparison to placebo.
Measured: Week 13
Patient Preference for Isosorbide Mononitrate Treatment at the End of Study.
Self reported participant preference for study period 1 vs. study period 2.
Measured: Week 13
Borg Score During 6 Minute Walk Test (Phase I)
To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. The Borg Scale consists of scale range of 0 to 10 (where 0 indicates no breathlessness at all and 10 indicates maximum breathlessness). Lower values are considered to be better than higher values.
Measured: Week 7
Borg Score During 6 Minute Walk Test (Phase II)
To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. The Borg Scale consists of scale range of 0 to 10 (where 0 indicates no breathlessness at all and 10 indicates maximum breathlessness). Lower values are considered to be better than higher values.
Measured: Week 13
Kansas City Cardiomyopathy Questionnaire Overall Summary Score (Phase I)
To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life).
Measured: Week 7
Kansas City Cardiomyopathy Questionnaire Overall Summary Score (Phase II)
To evaluate whether isosorbide mononitrate improves quality of life in comparison to placebo. • The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life).Higher values of the overall KCCQ score are considered to be better than lower values.
Measured: Week 13
N-terminal Pro-B-type Natriuretic Peptide Level (Phase I)
To evaluate whether isosorbide mononitrate improves natriuretic peptide levels in comparison to placebo
Measured: Week 7
N-terminal Pro-B-type Natriuretic Peptide Level (Phase II)
To evaluate whether isosorbide mononitrate improves natriuretic peptide levels in comparison to placebo
Measured: Week 13
Improvement in Daily Activity - Hours Active Per Day (Phase I)
To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Hours active per day during maximal dose of study drug
Measured: 5-6 weeks
Improvement in Daily Activity - Hours Active Per Day (Phase II)
To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Hours active per day during maximal dose of study drug
Measured: 11-12 weeks
Improvement in Daily Activity - Slope of Daily Average (Phase I)
To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Slope of daily averaged arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement.
Measured: 3-6 weeks
Improvement in Daily Activity - Slope of Daily Average (Phase II)
To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Slope of daily averaged arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement.
Measured: 9-12 weeks
Improvement in Daily Activity - Area Under the Curve (Phase I)
To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Area under the curve (AUC) of arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement. Area under the curve is defined as ((7*average acceleromtery units/day during 30 mg) + (7*average acceleromtery units/day during 60 mg) + (14*average acceleromtery units/day during 120 mg))/28
Measured: 3-6 weeks
Improvement in Daily Activity - Area Under the Curve (Phase II)
To evaluate whether isosorbide mononitrate in comparison to placebo improves daily activity as measured by Area under the curve (AUC) of arbitrary accelerometry units during study drug administration. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement. Area under the curve is defined as ((7*average acceleromtery units/day during 30 mg) + (7*average acceleromtery units/day during 60 mg) + (14*average acceleromtery units/day during 120 mg))/28
Measured: 9-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionFeb 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adrian Hernandez
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Mayo Clinic, University of Vermont
- Responsible party
- Sponsor-investigator, Adrian Hernandez, Duke University
- Investigators
- Kevin Anstrom, PhD, Principal investigator, Duke Clinical Research InstituteEugene Braunwald, MD, Study chair, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02053493
- Sponsor's protocol ID
- Pro00050042
- Other IDs
- 4U10HL084904-10
- Acronym
- NEAT-HFpeF
- Status last verified
- Oct 2016
- First submitted
- 3 Jan 2014
- Last updated
- 28 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: After the study results have been published, site-specific participant data will be shared with sites upon request. Sites are expected to follow their specific institutional policies regarding sharing results with their participants.
Publications
Reddy YNV, Rikhi A, Obokata M, Shah SJ, Lewis GD, AbouEzzedine OF, Dunlay S, McNulty S, Chakraborty H, Stevenson LW, Redfield MM, Borlaug BA. Quality of life in heart failure with preserved ejection fraction: importance of obesity, functional capacity, and physical inactivity. Eur J Heart Fail. 2020 Jun;22(6):1009-1018. doi: 10.1002/ejhf.1788. Epub 2020 Mar 9.
PubMed 32150314Snipelisky D, Kelly J, Levine JA, Koepp GA, Anstrom KJ, McNulty SE, Zakeri R, Felker GM, Hernandez AF, Braunwald E, Redfield MM. Accelerometer-Measured Daily Activity in Heart Failure With Preserved Ejection Fraction: Clinical Correlates and Association With Standard Heart Failure Severity Indices. Circ Heart Fail. 2017 Jun;10(6):e003878. doi: 10.1161/CIRCHEARTFAILURE.117.003878.
PubMed 28588021Redfield MM, Anstrom KJ, Levine JA, Koepp GA, Borlaug BA, Chen HH, LeWinter MM, Joseph SM, Shah SJ, Semigran MJ, Felker GM, Cole RT, Reeves GR, Tedford RJ, Tang WH, McNulty SE, Velazquez EJ, Shah MR, Braunwald E; NHLBI Heart Failure Clinical Research Network. Isosorbide Mononitrate in Heart Failure with Preserved Ejection Fraction. N Engl J Med. 2015 Dec 10;373(24):2314-24. doi: 10.1056/NEJMoa1510774. Epub 2015 Nov 8.
PubMed 26549714
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nitrate's Effect on Activity Tolerance in Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT02053493
- Acronym / sponsor ID
- NEAT-HFpeF / Pro00050042
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Preserved Ejection Fraction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Adrian HernandezUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Mayo Clinic, University of Vermont
- Study start
- Apr 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 3 Feb 2014 (estimated)
- Results
- Posted 28 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, double-blinded, placebo-controlled crossover study to assess effect of isosorbide mononitrate with dose up-titration on activity tolerance as assessed by (hip-worn, tri-axial) accelerometry.
Detailed description
To evaluate whether isosorbide mononitrate increases daily activity as assessed by 14-day averaged arbitrary accelerometry units in comparison to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isosorbide Mononitrate | Active comparator | Drug: Isosorbide MononitrateIsosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks) |
| Isosorbide Mononitate Placebo | Placebo comparator | Drug: PlaceboIsosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Age ≥ 50 years
- Symptoms of dyspnea (NYHA class II-IV) without evidence of a non-cardiac or ischemic explanation for dyspnea
- Ejection fraction (EF) ≥ 50% as determined on imaging study within 12 months of enrollment with no change in clinical status suggesting potential for deterioration in systolic function
- Stable medical therapy for 30 days as defined by:
- One of the following within the last 12 months
Key exclusion criteria (27 listed)
- Recent (< 3 months) hospitalization for HF
- Hemoglobin < 8.0 g/dl
- Glomerular filtration rate < 20 ml/min/1.73 m2 on most recent clinical laboratories
- SBP < 110 mmHg or > 180 mmHg at consent
- Diastolic blood pressure < 40 mmHg or > 100 mmHg at consent
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 |
|---|---|---|
| Isosorbide MononitrateAlso: Imdur, ISMO, MonoketDispense phase 1 study drug: Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN Dispense phase-2 study drug: Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN | Drug | Isosorbide Mononitrate |
| PlaceboDispense phase 1 study drug: Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo Dispense phase-2 study drug: Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo | Drug | Isosorbide Mononitate Placebo |
Primary outcome
Arbitrary Accelerometry Units (AAU) (Phase I)
Time frame: 5-6 weeks
To evaluate whether isosorbide mononitrate increases daily activity as assessed by 14-day averaged arbitrary accelerometry units in comparison to placebo. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement.
Arbitrary Accelerometry Units (AAU) (Phase II)
Time frame: 11-12 weeks
To evaluate whether isosorbide mononitrate increases daily activity as assessed by 14-day averaged arbitrary accelerometry units in comparison to placebo. An arbitrary accelerometer unit is calculated within the accelerometer device that is worn by the patient and represents level of activity based on patient movement. Higher values indicate more movement. 0 indicates no movement.
15 secondary outcomes
Six Minute Walk Distance (Phase I)
Time frame: Week 7
Six Minute Walk Distance (Phase II)
Time frame: Week 13
Patient Preference for Isosorbide Mononitrate Treatment at the End of Study.
Time frame: Week 13
Borg Score During 6 Minute Walk Test (Phase I)
Time frame: Week 7
Borg Score During 6 Minute Walk Test (Phase II)
Time frame: Week 13
Kansas City Cardiomyopathy Questionnaire Overall Summary Score (Phase I)
Time frame: Week 7
Kansas City Cardiomyopathy Questionnaire Overall Summary Score (Phase II)
Time frame: Week 13
N-terminal Pro-B-type Natriuretic Peptide Level (Phase I)
Time frame: Week 7
N-terminal Pro-B-type Natriuretic Peptide Level (Phase II)
Time frame: Week 13
Improvement in Daily Activity - Hours Active Per Day (Phase I)
Time frame: 5-6 weeks
Improvement in Daily Activity - Hours Active Per Day (Phase II)
Time frame: 11-12 weeks
Improvement in Daily Activity - Slope of Daily Average (Phase I)
Time frame: 3-6 weeks
Improvement in Daily Activity - Slope of Daily Average (Phase II)
Time frame: 9-12 weeks
Improvement in Daily Activity - Area Under the Curve (Phase I)
Time frame: 3-6 weeks
Improvement in Daily Activity - Area Under the Curve (Phase II)
Time frame: 9-12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32150314Reddy YNV, Rikhi A, Obokata M, Shah SJ, Lewis GD, AbouEzzedine OF, Dunlay S, McNulty S, Chakraborty H, Stevenson LW, Redfield MM, Borlaug BA. Quality of life in heart failure with preserved ejection fraction: importance of obesity, functional capacity, and physical inactivity. Eur J Heart Fail. 2020 Jun;22(6):1009-1018. doi: 10.1002/ejhf.1788. Epub 2020 Mar 9.
- Derived from this study: PubMed 28588021Snipelisky D, Kelly J, Levine JA, Koepp GA, Anstrom KJ, McNulty SE, Zakeri R, Felker GM, Hernandez AF, Braunwald E, Redfield MM. Accelerometer-Measured Daily Activity in Heart Failure With Preserved Ejection Fraction: Clinical Correlates and Association With Standard Heart Failure Severity Indices. Circ Heart Fail. 2017 Jun;10(6):e003878. doi: 10.1161/CIRCHEARTFAILURE.117.003878.
- Derived from this study: PubMed 26549714Redfield MM, Anstrom KJ, Levine JA, Koepp GA, Borlaug BA, Chen HH, LeWinter MM, Joseph SM, Shah SJ, Semigran MJ, Felker GM, Cole RT, Reeves GR, Tedford RJ, Tang WH, McNulty SE, Velazquez EJ, Shah MR, Braunwald E; NHLBI Heart Failure Clinical Research Network. Isosorbide Mononitrate in Heart Failure with Preserved Ejection Fraction. N Engl J Med. 2015 Dec 10;373(24):2314-24. doi: 10.1056/NEJMoa1510774. Epub 2015 Nov 8.
- Individual participant dataSharing planned: Yes. After the study results have been published, site-specific participant data will be shared with sites upon request. Sites are expected to follow their specific institutional policies regarding sharing results with their participants.
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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.
Kevin Anstrom, PhD principal investigator
Duke Clinical Research Institute
Eugene Braunwald, MD study chair
Harvard University
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Isosorbide Mononitrate in people with Heart Failure, run by Adrian Hernandez at 22 sites in United States.
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 24 inclusion and 27 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: finished, as of the sponsor's last update on 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. 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?
Yes. Results are posted in the registry (first posted 28 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Arbitrary Accelerometry Units (AAU) (Phase I) (time frame: 5-6 weeks). 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 NCT02053493, which also lists 3 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 28 Nov 2016.