Heart FailureMYH-IINCT05431192
Mind Your Heart-II
A study of Heart Failure and Cognitive Impairment, run by The Miriam Hospital at 1 site in United States.
Trial summary
This projects studies the role of mindfulness training (MT) to improve self-care among patients with heart failure and cognitive impairment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Cognitive Impairment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2022to Dec 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- A documented diagnosis of HF
- Access to a telephone
- Mild cognitive impairment (MoCA score < = 26)
- Ability to understand and speak English or Spanish
Who cannot join
- Unwillingness/inability to provide informed consent
- Reversible causes of HF (e.g., takotsubo syndrome; myocarditis)
- Severe hearing impairment not allowing phone delivery
- Suicidal ideation or plan
- Current (at least once a month) mind/body practice
- Planning to move out of the area during the study period
Show all 10Show fewer
- Severe cognitive impairment (MoCA scores < 15)
- New York Heart Association (NYHA) class IV heart failure or clinically unstable
- Ongoing psychiatric or neurologic conditions
- Current enrollment in another study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Targeting Cognitive Function and Interoceptive Awareness to Improve Self-management in Patients With Co-morbid Heart Failure and Cognitive Impairment.
This projects studies the role of mindfulness training (MT) to improve self-care among patients with heart failure and cognitive impairment.
Read the detailed description
Stable outpatients patients with co-morbid heart failure (HF) and mild cognitive impairment (MCI) (n=176) will be randomly assigned to phone-delivered MT (a weekly, 30-minute session for 8 weeks integrated with 20-min daily guided individual practice via digital recordings) plus enhanced usual care (EUC) or to EUC alone. Per current recommendations, usual care will be enhanced in both groups with self-care education materials. At baseline, 3 months (end of treatment), and 9 months since baseline participants will undergo comprehensive assessments of cognitive function, psycho-behavioral factors, cardiac vagal control, and HF biomarkers.
This study has the following objectives:
- To study the role of MT in improving cognitive function and HF self-care in patients with co-morbid HF and MCI. We hypothesize: 1a) Cognitive function will improve in MT vs. EUC at end of treatment (3 months); 1b) Improvements in cognitive function at end of treatment will mediate effects on self-care and HF biomarkers at follow-up (9 months since baseline).
- To study the role of MT in improving interoceptive awareness and HF self-care in patients with co-morbid HF and MCI. We hypothesize: 2a) Interoceptive awareness will improve in MT vs. EUC at 3 months, and 2b) Changes in interoceptive awareness at end of treatment will mediate improvements in self-care and HF biomarkers at 9 months follow-up.
- To study the mechanistic pathway linking MT, vagal control and cognitive function. We hypothesize: 3a) Vagal control will improve in MT vs. EUC at end of treatment (3 months); 3b) Changes in vagal control will mediate improvements in cognitive performance at 9 months of follow-up.
- Conditions
- Heart Failure, Cognitive Impairment
- Being tested
- Mindfulness Training + Enhanced Usual Care, Enhanced Usual Care
- Medical subject headings
- Heart Failure, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Training + Enhanced Usual CareBehavioural
Participants will receive a 30-minute, individual, phone-delivered session once a week for 8 weeks. MT involves training in the following (1) Awareness of breath; (2) Body scan; (3) Directing attention to simple activities of daily life; (4) Becoming aware of own thoughts and emotions; (5) "Open awareness" - a technique by which the participant is invited to direct his/her attention to any event arising in their field of experience at a given moment.
In addition, participants will practice mindfulness techniques for 20 minutes daily on their own with the guidance of a digitally recorded, standardized guided mindfulness practice.
Enhanced Usual CareOther
Usual care will be enhanced in BOTH conditions with printed education materials provided to all participants using publicly available materials (the "Healthier Living with Heart Failure" guide available at the AHA Heart Failure Resource Center).66 The guide is organized in 7 chapters containing information on topics such as understanding HF, making healthy lifestyle changes, managing HF symptoms, taking medications, and living well with HF. Printed materials will be mailed weekly to all participants during the first 8 weeks of the study.
| Study group | Role | What they receive |
|---|---|---|
| Mindful Training + Enhanced Usual Care | Experimental | Participants will receive a 30-minute, individual, phone-delivered session once a week for 8 weeks. Receives: Behavioral: Mindfulness Training + Enhanced Usual Care |
| Enhanced Usual Care alone | Other | Usual care. Receives: Other: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average Fluid Cognition Composite score from the NIH Toolbox Fluid Cognition Battery.
The NIH Toolbox is comprised of seven cognitive tests, of which two measure crystallized cognitive ability (i.e., vocabulary and reading) and five tests measure fluid cognitive functioning (i.e., working memory, memory, speed of processing, and executive function). The fluid cognition composite score is obtained by averaging the normalized scores of the Fluid Cognition measures. Higher scores indicate higher levels of functioning. A score ~ 100 indicates average fluid cognitive ability compared with others nationally. Scores ~115 suggest above-average ability, while scores ~130 suggest superior ability. Conversely, a score in the range of 85 suggests below-average ability, and a score ~ 70 or below suggests significant impairment.
Measured: Baseline, 3 months, 9 months
Secondary outcomes (7)
Change in average Multidimensional Assessment of Interoceptive Awareness (MAIA) scores.
The MAIA is a 32-item, self-report measure composed of eight individual scales, specifically: Noticing; Not Distracting; Not-Worrying; Attention Regulation; Emotional Awareness; Self-Regulation; Body Listening; and Trusting. Items are rated on a 6-point Likert scale (0-5) with '0' indicating 'Never' and '5' indicating 'Always'. Higher scores on each subscale indicate higher levels of interoceptive awareness.There are no standard normal values for each MAIA sub-scale; the range in previous samples from our group for the Not Distracting Score was 1-14. ; MAIA: Not Worrying Score 4-13; MAIA: Attention Regulation Score 4-35; MAIA: Emotional Awareness Score 5-25; MAIA: Self-Regulation Score 4-20; MAIA: Body Listening Score 1-15; MAIA: Trusting Score 3-15.
Measured: Baseline, 3 months, 9 months
Change in average Heart Failure (HF) Self-Care total scores.
The Self-care of HF Index (SCHFI) v.7.2., is a psychometrically valid, self-report instrument with three separate scales: Self-Care Maintenance (which captures treatment adherence and healthy behaviors), Symptom Perception (which assesses the ability to detect and interpret physical symptoms), and Self-Care Management (the response to symptoms when they occur). Reliability is > 0.70 and scores range from 0 to 100; higher scores indicate better self-care.
Measured: Baseline, 3 months, 9 months
Change in average Depression subscale score on the Hospital Anxiety and Depression Scale (HADS).
The HADS is a self-reported measure with two sub-scales (scores 0-21) measuring anxiety and depression, with higher scores indicating greater psychological morbidity. A good correlation has been reported between the HADS and other commonly used measures of depression. The HADS has been validated in cardiac patients.
Measured: Baseline, 3 months, 9 months
Change in average Kansas City Cardiomyopathy Questionnaire (KCCQ) Health Scores.
The Kansas City Cardiomyopathy Questionnaire (KCCQ) quantifies HF-specific physical limitations, symptom frequency, severity and change over time, overall quality of life, social interference, and knowledge. Responses are scored on a Likert scale and summed. Higher scores indicate higher quality of life. Construct validity and sensitivity of the KCCQ have been demonstrated.
Measured: Baseline, 3 months, 9 months
Change in high frequency power heart rate variability (hf-HRV) in Ln msec2.
High-frequency band is an index of cardiovagal control. High frequency power (hf-HRV) in Ln msec2 , a demonstrated index of vagal activity, will be determined by averaging high frequency values for 10 minute segments at each visit. The proposed methods are based on standards established in the literature.
Measured: Baseline, 3 months, 9 months
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP)levels.
NT-proBNP is a marker of HF disease severity, elevated filling pressures, clinical outcomes, and is responsive to interventions (e.g., exercise). Specimens are collected in a plastic EDTA tube , centrifuged and separated plasma samples are stored at -20°C until testing. Assays will be analyzed using the ADVIA Centaur BNP assay, a fully automated two-site sandwich immunoassay using direct chemiluminescent technology . The ADVIA Centaur BNP assay measures BNP concentrations up to 5000 pg/mL with a minimum detectable concentration (analytical sensitivity) of < 2.0 pg/mL and shows high specificity for BNP.
Measured: Baseline, 3 months, 9 months
Change in average 6-min walk test (6MWT) distance.
The 6MWT measures the distance a patient can walk on a level course in 6 min. It is a measure of functional capacity that correlates with peak oxygen uptake and is positively associated with survival in patients with cardiovascular disease. A higher value (in meters) indicates better functional capacity. The 6MWT distance in healthy adults has been reported to range from 400 to 700 meters.
Measured: Baseline, 3 months, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start30 Nov 2022
- Primary completion31 Jul 2026
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Elena Salmoirago-Blotcher, The Miriam Hospital
- Investigators
- Elena Salmoirago-Blotcher, MD, PhD, Principal investigator, Cardiovascular Institute, The Miriam Hospital, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431192
- Sponsor's protocol ID
- R01AG076438
- Other IDs
- R01AG076438
- Acronym
- MYH-II
- Status last verified
- Aug 2026
- First submitted
- 20 Jun 2022
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data generated under the project will be shared as per the NIH Grant Policy and The Miriam Hospital IRB guidelines. Deidentified research data will be made available in a timely manner once the main findings from the final research data set have been accepted for publication. Access to these data will be available for educational or research purposes. Data will be deidentified to avoid linkages to individual research participants and will not contain variables that could lead to the disclosure of the identity of individual subjects. All requestors will be asked to sign a data sharing agreement that includes conditions to 1) protect the identity of participants, 2) limit use of data for educational and research purposes, 3) prevent transfer of data to other users, and 4) acknowledge the data source. The de-identified data will be shared using Excel or SPSS file formats.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Cognitive Function and Interoceptive Awareness to Improve Self-management in Patients With Co-morbid Heart Failure and Cognitive Impairment.
- ClinicalTrials.gov ID
- NCT05431192
- Acronym / sponsor ID
- MYH-II / R01AG076438
- Conditions
- Heart Failure, Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Jun 2022 (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.
This projects studies the role of mindfulness training (MT) to improve self-care among patients with heart failure and cognitive impairment.
Detailed description
Stable outpatients patients with co-morbid heart failure (HF) and mild cognitive impairment (MCI) (n=176) will be randomly assigned to phone-delivered MT (a weekly, 30-minute session for 8 weeks integrated with 20-min daily guided individual practice via digital recordings) plus enhanced usual care (EUC) or to EUC alone. Per current recommendations, usual care will be enhanced in both groups with self-care education materials. At baseline, 3 months (end of treatment), and 9 months since baseline participants will undergo comprehensive assessments of cognitive function, psycho-behavioral factors, cardiac vagal control, and HF biomarkers.
This study has the following objectives:
- To study the role of MT in improving cognitive function and HF self-care in patients with co-morbid HF and MCI. We hypothesize: 1a) Cognitive function will improve in MT vs. EUC at end of treatment (3 months); 1b) Improvements in cognitive function at end of treatment will mediate effects on self-care and HF biomarkers at follow-up (9 months since baseline).
- To study the role of MT in improving interoceptive awareness and HF self-care in patients with co-morbid HF and MCI. We hypothesize: 2a) Interoceptive awareness will improve in MT vs. EUC at 3 months, and 2b) Changes in interoceptive awareness at end of treatment will mediate improvements in self-care and HF biomarkers at 9 months follow-up.
- To study the mechanistic pathway linking MT, vagal control and cognitive function. We hypothesize: 3a) Vagal control will improve in MT vs. EUC at end of treatment (3 months); 3b) Changes in vagal control will mediate improvements in cognitive performance at 9 months of follow-up.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindful Training + Enhanced Usual Care | Experimental | Behavioral: Mindfulness Training + Enhanced Usual CareParticipants will receive a 30-minute, individual, phone-delivered session once a week for 8 weeks. |
| Enhanced Usual Care alone | Other | Other: Enhanced Usual CareUsual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years old
- A documented diagnosis of HF
- Access to a telephone
- Mild cognitive impairment (MoCA score < = 26)
- Ability to understand and speak English or Spanish
Key exclusion criteria (10 listed)
- Unwillingness/inability to provide informed consent
- Reversible causes of HF (e.g., takotsubo syndrome; myocarditis)
- Severe hearing impairment not allowing phone delivery
- Suicidal ideation or plan
- Current (at least once a month) mind/body practice
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 |
|---|---|---|
| Mindfulness Training + Enhanced Usual CareParticipants will receive a 30-minute, individual, phone-delivered session once a week for 8 weeks. MT involves training in the following (1) Awareness of breath; (2) Body scan; (3) Directing attention to simple activities of daily life; (4) Becoming aware of own thoughts and emotions; (5) "Open awareness" - a technique by which the participant is invited to direct his/her attention to any event arising in their field of experience at a given moment. In addition, participants will practice mindfulness techniques for 20 minutes daily on their own with the guidance of a digitally recorded, standardized guided mindfulness practice. | Behavioural | Mindful Training + Enhanced Usual Care |
| Enhanced Usual CareUsual care will be enhanced in BOTH conditions with printed education materials provided to all participants using publicly available materials (the "Healthier Living with Heart Failure" guide available at the AHA Heart Failure Resource Center).66 The guide is organized in 7 chapters containing information on topics such as understanding HF, making healthy lifestyle changes, managing HF symptoms, taking medications, and living well with HF. Printed materials will be mailed weekly to all participants during the first 8 weeks of the study. | Other | Enhanced Usual Care alone |
Primary outcome
Change in average Fluid Cognition Composite score from the NIH Toolbox Fluid Cognition Battery.
Time frame: Baseline, 3 months, 9 months
The NIH Toolbox is comprised of seven cognitive tests, of which two measure crystallized cognitive ability (i.e., vocabulary and reading) and five tests measure fluid cognitive functioning (i.e., working memory, memory, speed of processing, and executive function). The fluid cognition composite score is obtained by averaging the normalized scores of the Fluid Cognition measures. Higher scores indicate higher levels of functioning. A score ~ 100 indicates average fluid cognitive ability compared with others nationally. Scores ~115 suggest above-average ability, while scores ~130 suggest superior ability. Conversely, a score in the range of 85 suggests below-average ability, and a score ~ 70 or below suggests significant impairment.
7 secondary outcomes
Change in average Multidimensional Assessment of Interoceptive Awareness (MAIA) scores.
Time frame: Baseline, 3 months, 9 months
Change in average Heart Failure (HF) Self-Care total scores.
Time frame: Baseline, 3 months, 9 months
Change in average Depression subscale score on the Hospital Anxiety and Depression Scale (HADS).
Time frame: Baseline, 3 months, 9 months
Change in average Kansas City Cardiomyopathy Questionnaire (KCCQ) Health Scores.
Time frame: Baseline, 3 months, 9 months
Change in high frequency power heart rate variability (hf-HRV) in Ln msec2.
Time frame: Baseline, 3 months, 9 months
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP)levels.
Time frame: Baseline, 3 months, 9 months
Change in average 6-min walk test (6MWT) distance.
Time frame: Baseline, 3 months, 9 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 5 Aug 2026.
- Individual participant dataSharing planned: Yes. Data generated under the project will be shared as per the NIH Grant Policy and The Miriam Hospital IRB guidelines. Deidentified research data will be made available in a timely manner once the main findings from the final research data set have been accepted for publication. Access to these data will be available for educational or research purposes. Data will be deidentified to avoid linkages to individual research participants and will not contain variables that could lead to the disclosure of the identity of individual subjects. All requestors will be asked to sign a data sharing agreement that includes conditions to 1) protect the identity of participants, 2) limit use of data for educational and research purposes, 3) prevent transfer of data to other users, and 4) acknowledge the data source. The de-identified data will be shared using Excel or SPSS file formats.
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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.
Elena Salmoirago-Blotcher, MD, PhD principal investigator
Cardiovascular Institute, The Miriam Hospital, Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Heart Failure and Cognitive Impairment, run by The Miriam Hospital at 1 site 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 5 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2026. 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 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. 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?
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?
Change in average Fluid Cognition Composite score from the NIH Toolbox Fluid Cognition Battery. (time frame: Baseline, 3 months, 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2026.