All subjects will receive Ivabradine 7.5mg twice daily for 2 weeks in a double-blind randomized crossover design.

All subjects will receive matching placebo tablets twice daily for 2 weeks in a double-blind randomized crossover design.

Heart Failure

Ivabradine

Univesrtity of Oxford, John Radcliffe Hospital

The Role of Chronotropic Incompetence in Heart Failure With Normal Ejection Fraction (HFNEF)

A Mechanistic Study to Assess The Role of Chronotropic Incompetence in Heart Failure With Normal Ejection Fraction (HFNEF)

University of Oxford

University of Aberdeen

One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.

One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.

One capsule will be taken (dextromethorphan HB and quinidine sulfate, 20 mg/10 mg) daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Dextromethorphan and quinidine

Nuedexta

One capsule will be taken of placebo to match daily for seven days. On the eight day and for the remainder of the study 2 capsule will be taken twice a day. Medication will be taking daily for a total of 3 months.
Placebo

Placebo

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

Number of headache days reported during the 28 day run-in period.

Headache Days

Number of migraine days reported during the 28 day run-in period.

Migraine Days

Headache pain severity reported during the 28 day run-in period. Measured on a scale from 1 = Mild, to 3 = Severe. Higher numbers indicating more severe headache pain.

Headache Severity

Average headache duration reported during the 28 day run-in period, measured in hours.

Headache Duration

Number of doses of acute medication taken, reported during the 28 day run-in period.

Acute Medication Use

The average number of headache days at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm. Headache days were defined as any patient reported head pain during the prior 24 hour period.

Headache Days in Each Treatment Period Month

The average number of headache days at treatment period month 3 (28 day period) for the Nuedexta arm and the Placebo arm. Headache days were defined as any patient reported head pain during the prior 24 hour period.

Headache Days in Treatment Period Month 3

The average number of migraine days at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm.

Migraine Days in Each Treatment Period Month

The average headache severity at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm. Headache pain severity was measured on a scale from 1 = Mild, to 3 = Severe. Higher numbers indicating more severe headache pain.

Headache Severity in Each Treatment Period Month

The average headache duration (time of onset to pain free) at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm. Headache duration was measured in hours.

Headache Duration in Each Treatment Period Month

The number of subjects with at least a 50% reduction in number of headache days comparing baseline to each visit (treatment period months 1, 2, and 3: 28 day for each month) in the Nuedexta arm vs. the placebo arm.

50% Headache Reduction

The average number of doses of acute medication taken at treatment period months 1, 2, and 3 (28 day periods for each month) for the Nuedexta arm and the Placebo arm

Acute Medication Use in Each Treatment Period Month

MIDAS scores at Visit 2 and Visit 5 (end of treatment period month 3). The MIDAS is a questionnaire consisting of five (5) "how many days in the last 3 months..." questions. Thus the range for the MIDAS is from, 0 to a maximum possible score 93 (31 days X 3 months). The MIDAS is scored according to the following:
0-5, MIDAS Grade I, Little or No Disability 6-10, MIDAS Grade II, Mild Disability 11-20, MIDAS Grade III, Moderate Disability 21+, MIDAS Grade IV, Severe Disability

Migraine Disability Assessment Scale (MIDAS)

Headache Health Score at Visit 2 (Day 28), Visit 3 (Day 57), Visit 4 (Day 85), and Visit 5 (Day 116) for the Nuedexta arm and the placebo arm. The Headache Health Score is measured using a scale from 0 to 100, with higher scores indicating less headache impact on the subject's life.

Headache Health Score

Compare the number of adverse events in the Nuedexta arm vs. the placebo arm.

quinidine/головная боль

The Role of Chronotropic Incompetence in Heart Failure With Normal Ejection Fraction (HFNEF)

Nuedexta for the Prevention and Modification of Disease Progression in Episodic Migraine

Самая полная база данных о лекарственных травах, подтвержденная наукой