Severe Aortic Stenosis

Iron-deficiency

The active drug, iron isomaltoside, will be administered as a single, intravenous infusion of 20 mg/kg body weight (rounded off to the nearest 100 mg) dissolved in 100 ml NaCl as recommended by the drug manufacturer ("on-label" treatment), over 30 minutes only (1,67 ml/min).

Intravenous iron isomaltoside

The placebo will be prepared according to the randomisation code, and administered as a single intravenous infusion over 30 minutes only (1,67 ml/min).

Placebo

Rikshospitalet University Hospital

Intravenous Iron Supplement for Iron Deficiency in Patients With Severe Aortic Stenosis

Intravenous Iron Supplement for Iron Deficiency in Patients With Severe Aortic Stenosis: The IIISAS Trial

The baseline-adjusted distance walked on a 6 min walk test performed 6 months after the trial intervention.

Iron deficiency defined as serum ferritin < 100 µg/l or ferritin between 100 and 300 µg/l in combination with a transferrin saturation < 20 %.

Grip strength will be measure using a hand-held dynamometer (hand-grip device).

The SF-36 Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.

EQ-VAS is an instrument to measure overall health on a vertical visual analogue scale, ranging from "worst possible" (zero) to "best possible" (100)health.

HADS is a fourteen item scale used to determine the levels of anxiety and depression that a person is experiencing. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.

KCCQ is a 23-item, self administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. The responses are categorized under 3 subscales (symptom burden, physical limitation and quality of life) with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms.

CANTAB (www.cambridgecognition.com) is a computer-based cognitive assessment system consisting of a battery of seven neuropsychological tests, administered to subjects using a touch screen computer. Automatic scoring, adjusted for age, gender and education level.

NT-proBNP is measured as a simple blood test and used as diagnostic biomarker for heart failure and cardiac dysfunction in clinical medicine.

TnT is measured as a simple blood test and used as a standard biomarker of myocardial injury.

The standard time period for collecting and recording AE and SAEs will begin at the start of study treatment and the mandatory reporting of new AEs ends after the end-of-study visit 6 months after study drug infusion.

Lars Gullestad

Professor

Oslo University Hospital

All patients in the study will be assigned to receive menaquinone 360 μg /d for 4 weeks.

Vascular Calcifications

Patients on hemodialysis will be supplemented by 360 μg /d of menaquinone for 4 weeks. At baseline they will have a lateral abdominal X-Ray and dosage of dp-ucMGP. At the end of the study patients will have a second measurement of dp-ucMGP levels.

Menaquinone

Saint-Georges Hospital

Risk Factors for Vascular Calcifications in Hemodialysis Patients: to What Extent is Vitamin K2 Deficiency Involved?

We will analyze whether the percentage of decrease of dp-ucMGP in our Middle-Eastern country following vitamin k2 supplementation is similar to that reported in the previous trials in Europe.

Mabel Aoun

Head of the Department of Nephrology, Saint-Georges Hospital Ajaltoun

Saint-Joseph University

Patients with resistant hypertension and chronic kidney disease (GFR between 15 and 60) will receive Renal Denervation as a treatment

Chronic Kidney Disease

The Symplicity Renal Denervation System is indicated for the delivery of low-level radiofrequency energy through the wall of the renal artery to denervate the kidney and reduce blood pressure in adult patients with refractory hypertension. The Symplicity Generator delivers controlled relatively low power radiofrequency energy (approximately 8 watts for 2 minutes). The Symplicity System selectively denervates the kidney by delivering radiofrequency from the generator via the electrode of the catheter through the renal artery wall from the intra-luminal side to ablate the renal sympathetic efferent and afferent nerves and reduce overall sympathetic nervous system activity.

Renal Denervation

Regina Qu'Appelle Health Region

Renal Denervation in Patients With Chronic Kidney Disease

Prairie Renal Denervation Study

measured using ATCOR machine: Augmentation index (%) Augmentation pressure (mm Hg) Central pulse pressure (mm Hg) Central systolic pressure (mm Hg) Central diastolic pressure (mm Hg) Pulse pressure amplification (mm Hg) Time to reflection (Tr) in ms Pulse Wave Velocity

Using an echocardiogram, the following cardiac measures will be taken:
Left ventricle volume Left ventricle hypertrophy Left ventricle function Left atrial mass E-wave velocity E-prime velocity

systolic and diastolic blood pressure (mm Hg) measured using BP-Tru machine.

systolic and diastolic blood pressure (mm Hg) measured using BP-Tru machine

For 24-hour blood pressure, we will record the following:
12-hour daytime Systolic Pressure (mm Hg) 12-hour daytime Diastolic Pressure (mm Hg) 12-hour nighttime Systolic Pressure (mm Hg) 12-hour nighttime Diastolic Pressure (mm Hg)

aortic valve stenosis/albumine

Intravenous Iron Supplement for Iron Deficiency in Patients With Severe Aortic Stenosis

Risk Factors for Vascular Calcifications in Hemodialysis Patients: to What Extent is Vitamin K2 Deficiency Involved?

Renal Denervation in Patients With Chronic Kidney Disease

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